The CATALYST Study

March 12, 2025 updated by: FHI 360

The CATALYST Study: Catalyzing Access to New Prevention Products to Stop HIV

The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at PEPFAR sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The overall study goal is to characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at U.S. President's Plan for AIDS Relief/U.S. Agency for International Development (PEPFAR/USAID) delivery sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. The study will be conducted in two stages, with currently approved oral PrEP and PrEP rings offered in Stage I, and the addition of CAB PrEP in Stage II after it has been approved by the regulatory authority in each country. The study goal will be accomplished by conducting a mixed-methods implementation study involving several components:

  1. Component 1: Prospective cohort study of women at PEPFAR/USAID delivery sites that are delivering HIV PrEP, including daily oral PrEP, monthly PrEP rings, and bimonthly CAB PrEP

    1. Descriptive nested cohort study to evaluate the performance characteristics of different HIV testing strategies among participants who initiate CAB PrEP
    2. Descriptive nested cohort study to evaluate the feasibility and validity of a prevention effective use (PEU) measure among a subset of PrEP users

  2. Component 2: Mixed-methods process evaluation involving implementers and key stakeholders

    1. Nested costing study across Lesotho, Uganda, and Zimbabwe study sites
    2. Nested qualitative study to understand community acceptance of PrEP and informed choice of PrEP products

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6069

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Chulaimbo sub-country hospital
      • Kisumu, Kenya
        • Migosi Health
      • Mombasa, Kenya
        • Likoni Sub-country hospital
      • Mombasa, Kenya
        • Tudor sub-country hospital
      • Nairobi, Kenya
        • Bar Hostess Empowerment & Support Programme (BHESP) Drop-In Centre
      • Nairobi, Kenya
        • Mukuru Public Health Centre
  • Lesotho
      • Maseru, Lesotho
        • Sefika
      • Morija, Lesotho
        • Scott Hospital
      • Teyateyaneng, Lesotho
        • Berea
  • South Africa
      • Hennenman, South Africa
        • Phomolong Clinic
      • Johannesburg, South Africa
        • FSW Esselen Street
      • Johannesburg, South Africa
        • TG Esselen Street
      • Welkom, South Africa
        • Hani Park Clinic
      • Welkom, South Africa
        • Matjhabeng Clinic
      • Welkom, South Africa
        • Welkom Clinic
  • Uganda
      • Gulu, Uganda
        • Gulu RRH
      • Ibanda, Uganda
        • Bufunda HC III
      • Kitgum, Uganda
        • Kitgum Hospital
      • Mbale, Uganda
        • Namakwekwe HC III
      • Mbarara, Uganda
        • Mbarara HC IV
      • Tororo, Uganda
        • Bison HCCIII
      • Tororo, Uganda
        • Malaba HC III
  • Zimbabwe
      • Beitbridge, Zimbabwe
        • Beitbridge Wellness Clinic
      • Bulawayo, Zimbabwe
        • Cowdray Park Clinic
      • Bulawayo, Zimbabwe
        • Plumtree District Hospital
      • Chitungwiza, Zimbabwe
        • SHAZ! Hub (Citimed Hopstial)
      • Masvingo, Zimbabwe
        • Runyararo Clinic
      • Ngundu, Zimbabwe
        • Ngundu Rural Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

HIV-negative women* attending PEPFAR/USAID-supported facilities who are interested in learning about HIV prevention and are otherwise eligible to participate in the study

*Presumed HIV-negative based on results from the national testing algorithm. For this study, the term "women" is inclusive of individuals assigned female at birth of any gender identity or individuals assigned male at birth who identify as women, although this definition is subject to local country guidelines.

Description

Inclusion Criteria:

  • Tested HIV-negative as determined by the national HIV testing algorithm at a CATALYST site on the same day as enrollment

  • Self-identify with at least one of the following populations:

    1. Adolescent girl or young women (AGYW) ages 15-24 years
    2. Female sex worker (FSW) ages 18 years and older
    3. Pregnant and breastfeeding populations (PBFP) ages 15 years and older
    4. Individuals assigned female at birth of any gender identity ages 15 years and older
    5. Individuals assigned male at birth who identify as women ages 15 years and older
    6. Other women ages 25 years and older
  • Interested in learning about HIV prevention
  • Willing to be contacted for follow-up by phone or other means (e.g., through a community health worker)
  • Willing and able to provide informed written consent for participation

Exclusion Criteria:

  • For participants ages 15-17 years, potential participants under the age of 18 may be excluded from study participation based on country guidelines and the age of consent. This determination will vary by country, including countries' definitions of emancipated minors. Country-specific informed consent forms will outline the country-specific inclusion criteria related to age.
  • Certain sub-categories of participants may be excluded based on country guidelines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall and method-specific PrEP method uptake
Time Frame: 24 months
Proportion of cohort members who initiate oral PrEP, the PrEP ring, CAB PrEP, or decline all PrEP or are ineligible for PrEP
24 months
Patterns of PrEP use
Time Frame: 24 months
Person-time of continued use of a certain PrEP method, until switching to another method or missed resupply; Person-time of pause between missed resupply and reinitiation or switching (subset).
24 months
Qualitative assessment of health system feasibility
Time Frame: 24 months
The extent to which PrEP choice and the enhanced service delivery package can be successfully carried out at facilities within health systems involved in CATALYST. This measure will be assessed through qualitative data collected through periodic in-depth interviews conducted among PrEP providers, community stakeholders, and key informants at selected sites.
24 months
Delivery acceptability among providers measured using an adapted version of the Acceptability of Intervention Measure (AIM)
Time Frame: 24 months
Perception that offering informed choice of PrEP products and the provision of the enhanced service delivery package are agreeable or satisfactory in this setting as measured though an adapted version of the acceptability of intervention measure (Weiner et al. 2017), a 5-item scale with higher scores representing greater acceptability (range: 5-25).
24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost of delivery at a subset of study sites
Time Frame: 24 months
The cost of the implementation effort, including average unit cost estimates for oral PrEP, the PrEP ring, and CAB PrEP in Lesotho, Uganda, and Zimbabwe and the incremental unit cost of adding PrEP ring and CAB PrEP at sites already providing oral PrEP
24 months
Qualitative assessment of community acceptability of PrEP and PrEP choice
Time Frame: 24 months
Perception that PrEP (and PrEP choice) are agreeable, satisfactory, and welcomed in the community, especially among primary PrEP influencers (partners and parents/caregivers). This measure will be assessed through qualitative in-depth interviews conducted among primary PrEP influencers in select CATALYST communities, including parents/caregivers of existing and potential PrEP users and partners of existing and potential PreP users.
24 months
Product acceptability among users as assessed through a theory-informed questionnaire relating to different aspects of acceptability (Sekhon et al., 2022)
Time Frame: 24 months
Perception that PrEP product is agreeable or satisfactory. This measure will be assessed through administration of an adapted version of the theory-informed questionnaire developed by Sekhon et al., 2022. Item scores will be reported separately for each acceptability construct.
24 months
Prevention effective use of PrEP products
Time Frame: 24 months
Percent of risk-days (days with condomless sex) when participants were protected from HIV acquisition by taking PrEP based on reported daily occurrence within certain periods. Note that this measure will only be reported if measure passes validation assessment conducted early in the implementation period.
24 months
Rates of HIV infection among participants
Time Frame: 24 months
Number of study cohort members who become infected with HIV at any point during the study disaggregated by PrEP use status after enrollment (but not including the enrollment visit).
24 months
Rates of HIV drug resistance among PrEP users who acquire HIV during study participation
Time Frame: 24 months
Number and type of HIV drug resistance-associated polymorphisms and/or mutations identified among participants who become infected with HIV and were exposed to PrEP
24 months
Pregnancy and selected infant outcomes among pregnant and breastfeeding populations for outcomes occurring during the study period.
Time Frame: 24 months
Among pregnant participants reporting exposure to PrEP during pregnancy: type and frequency of pregnancy outcomes (term live birth [≥37 weeks], preterm live birth [<37 weeks], pre-term birth, stillbirth, birth weight and sex, spontaneous abortion, congenital anomalies, gestational age, neonatal death) among outcomes occurring during the study period
24 months
Frequency of reported side effects by PrEP product
Time Frame: 24 months
The type, number, and perceived severity of patient-reported side effects from PrEP product use
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FHI 360

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Agency for International Development (USAID)
Jhpiego
Wits Reproductive Health and HIV Institute
Pangaea Zimbabwe Aids Trust
LVCT Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elizabeth Irungu, Jphiego
  • Principal Investigator: Nicolette Naidoo, Wits RHI
  • Principal Investigator: Carolyne Akello, FHI 360 Uganda
  • Principal Investigator: Kevin K'Orimba, LVCT Health
  • Study Chair: Virginia Fonner, FHI 360
  • Principal Investigator: Emily Gwavava, Pangaea Zimbabwe Aids Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FHI 360 CATALYST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with the USAID Automated Directives System 579, after acceptance of any knowledge product presenting study findings and after being cleaned of any information that could be used to personally identify participants, the quantitative survey dataset along with relevant documentation will be registered with USAID's Development Data Library (DDL) and made publicly available in an open data repository, to the extent permissible by participating countries' privacy and data sharing regulations.

IPD Sharing Time Frame

After study completion and manuscript submission.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Prevention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings